Plasma Kinetics of Levobupivacaine After Transversus Abdominis Plane (TAP) Block in Abdominal Surgery

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Conditions studied: Abdominal Surgery Patients, Transversus Abdominis Plane (TAP) Block, Pharmacokinetic Analysis, Levobupivacaine, Local Anaesthetic Systemic Toxicity

In brief

This prospective single-center observational pharmacokinetic study will evaluate plasma levobupivacaine concentrations after ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing elective abdominal surgery under general anesthesia at CHU Liège. Participants receiving TAP block as part of standard clinical care (levobupivacaine 0.375%, total volume 40 mL, maximum dose 150 mg) will undergo serial blood sampling at 3, 7, 15, 30, 60, 120, and 180 minutes after block completion. Plasma levobupivacaine concentrations will be measured using validated LC-MS/MS methods. The primary objectives are to estimate maximum plasma concentration (Cmax) and time to maximum concentration (Tmax). Secondary objectives include characterization of the concentration-time profile, AUC0-180, interindividual variability, and exploratory associations with clinical factors (age, sex, BMI, type of surgery). The study also aims to inform a pragmatic safety window for subsequent intravenous lidocaine infusion used in multimodal analgesia protocols. Approximately 26 participants will be enrolled. No modification of routine anesthesia or analgesic care is required apart from study-related blood sampling.

Key facts

Study ID

NCT07581275

Run by

University of Liege

People needed

26

Starts

2026-07-01

Expected to finish

2026-12-15

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Scheduled elective abdominal surgery under general anesthesia
• Planned ultrasound-guided TAP block as part of standard perioperative analgesic care
• Able to understand and speak French sufficiently to understand the study information and consent form
• Able and willing to provide written informed consent

You may not qualify if…

• Refusal or inability to provide informed consent
• Known allergy or hypersensitivity to amide local anesthetics
• Severe hepatic impairment
• Renal impairment (estimated glomerular filtration rate <50 mL/min/1.73 m²)
• Contraindication to repeated blood sampling or inability to complete the sampling schedule
• Participation in another clinical study that could affect absorption, distribution, metabolism, or elimination of local anesthetics
• Pregnancy
• Emergency surgery or life-threatening urgent condition
• Immediate postoperative instability requiring intensive care transfer (e.g., hemodynamic instability)
• Inability to understand French sufficiently for study information and consent
• Persons requiring special legal protection for consent (e.g., minors, guardianship, incapacity to consent)

Full record on ClinicalTrials.gov

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